306 Mdr Jobs - Page 11

Job Title Mechanical Designer Job Description J ob title: Mechanical Designer In this role, you will have the opportunity to participate in an exciting and progressive environment developing products that save lives. You will be part of the remediation, relaunch (MLD) and NPI (New Product Introduction) Mechanical Engineering Team within the R&D (Research and Development) Department at Philips SRC (Sleep and Respiratory Care) division. You will be directly involved in the design and development of Ventilators (hospital and home) and disposables (masks). Your role: 1. Lead Sustenance activities for respiratory products. 2. Support ongoing MDD and MDR regulatory compliance. 3. Lead and execution remediation tasks. 4. Execute any verification activities – as required in the lab for elements and parts. 5. Support DHF (design history file) remediation for mechanical engineering deliverables which includes; defining strategy and planning, gap analysis, creating new and revising DHFs, reviewing and releasing DHFs. 6. DHF’s accountability and responsibility for mechanical and mechatronic parts and sub systems (Gas path, valves, sensors (air, O2 and Pressure), manifold, patient interface, solenoid valves, filters, blowers, motors and enclosure). 7. Review & mentor - correctness and approve design documentation including requirements specification, design docs, engineering analysis & simulation studies, calculations, capture, test plans, test procedures, test records & reports. 8. Lead project team members to produce development plans and identify and mitigate development risks. 9. Conceive, design, develop, evaluate, and implement new systems and products in the field of medical ventilator product development and sustaining engineering. 10. Utilize best practices in mechanical design analysis, modeling, and tolerance analysis to produce a highly viable mechanical. 11. Create documentation, including component details, assembly details, incoming and finished inspection requirements, using CAD (Computer Aided Design) as a design tool. 12. Responsible for all aspects of design documentation including requirements specification, engineering analysis, drawings, test plans/procedures, validation, the release of components, assemblies and products to production, and production startup support. 13. Supports the manufacturing engineering team in troubleshooting and resolving issues discovered during production. 14. Be a self-starter, action oriented, organized and disciplined. 15. Keep abreast of technical developments in own field through literature, technical contacts, and industry competition. 16. Work in close co-ordination with PMG and manufacturing engineering for resolution of issues as they arise during sample build phases and actual production. 17. Lead & or support CAPA activities for closure of CAPA with effective implementation of containment, corrective and preventive actions. 18. Lead RCA investigation for any issues arises in the plant or in the field using fish bone diagrams, probable and potential causes, why-why analysis, replicating issues in the lab and taking containment and corrective actions for re-occurrence prevention. You're the right fit if: Bachelor’s or Master's degree in Mechanical or Mechatronics Engineering. Minimum of 8 years' experience in the design and analysis role. Experience in design and analysis of medical ventilators or medical gas delivery systems a plus. Experience leading a technical team in product development. In depth knowledge of pneumatic systems including pressure and flow sensing. Experience in the design and analysis of low and medium pressure gas valves. Experience with low pressure gas blowers. Experience with Computational Fluid Dynamics. Experience in the design of plastic injection molded parts. Knowledge of ASME (American Society of Mechanical Engineers) Y14.5 Dimensioning and Tolerancing. Proficiency with solid modeling CAD software (Pro-E/Creo a plus). Good mechanical aptitude and solid understanding of mechanical engineering principles. Effective communication skills, both oral and written. Familiarity with FDA (Food and Drug Administration (USA)) quality systems including ISO13485, 21CFR Part820 (a plus). Familiarity and experience with SAP, Windchill, MBSE tools, CITOL, Ansys WB would be added advantage. About Philips We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others. Learn more about our business . Discover our rich and exciting history . Learn more about our purpose . If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here . #LI-PHILIN #DIW

The Opportunity The incumbent is responsible for selling to new channel partners/distributors and cross/up/repeat sales to existing channel partners/distributors. Maintain existing relationships with organizations distributing products, services and/or solutions. Deliver product demonstrations, sales bids and presentations to channel partners/distributors. Manage the relationship with the channel partners/distributors. What we're looking for Education Science Graduates or Postgraduates / MBA are preferred. Experience Minimum of 8+ years of IVD sales experience required How you will thrive and create an impact Develops and executes territory plan to achieve revenue targets and control expenses. Works with channel partners where appropriate to drive specific opportunities. Establishes high-level customer and distributor relationship/intimacy by way of technical and business skills/competencies and situational fluency. Understands current customer processes and applications and communicates customer technology product requirements to internal stakeholders. Utilizes a variety of communication and engagement methodologies including quarterly business reviews, executive meetings and technical collaborations; ensures they meet the targeted number of face to face key account interactions per week. Demonstrates effective employee relationships built on trust, teamwork and accountability. Performs other duties as assigned with or without accommodation. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer. Why Avantor? Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science. The work we do changes peoples lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his moms voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor. We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today! EEO Statement: We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. 3rd party non-solicitation policy: By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation

QA & IATF Documentation, CAPA Analysis, SPC, MSA, Control Plan, FMEA, MDR Requirement, Cleanroom Validation, Calibration Work, Lab equipment handling, Rheo logy, Visco matter, VTM, Develop and Implement QA Processes

DESIGNATION: ANALYST DESIGN QUALITY ENGINEER Contract Duration: 12 - 24 Months PRIMARY RESPONSIBILITIES: Ensures that designs meet regulatory requirements, quality standards, and company policies throughout the product lifecycle (FDA 21CFR Part 820 Quality System Regulation, ISO 13485 Regulations, ISO 14971) Review design documentation, specifications, and data to identify potential compliance gaps and quality issues. Responsible for developing and implementing compliance programs, identifying potential issues, and recommending corrective actions to ensure product safety, reliability, and efficacy. Maintain accurate and up-to-date documentation related to compliance activities, including test results, reports, and procedures. Hands-on experience in Design History File compilation / Technical file documentation. Experience in complaint investigation, corrective action and preventive action system, statistical methods, quality risk management and Post Market Surveillance. Possess a strong understanding of design principles, quality control standards, regulatory requirements, and problem-solving methodologies. QUALIFICATION: A graduate in Mechanical or related engineering and with 4-6 years related medical device /combination product design & development experience and product lifecycle management.

Job Position: PMS Service – Medical Devices Complaints Handling Job Description: To handle medical device customer allegations in complaints management system . Candidate with knowledge on Medical devices usage, Complaint Evaluation, Investigation, Medical devices reporting including post-market surveillance (PMS) and CAPA.Roles and Responsibilities:To work on Complaint handling Process – Evaluation, Regulatory Assessment, InvestigationWork with lead in completing daily assignation.Organize and manage daily work allocationComplaints remediation using work instruction, compliance to processTo drive efficiency and compliance.Collaborate with of cross function team (CFT) such as Intake, MDR, Investigation to execute the project and initiative.Daily status to lead associateSkills:2 to 4 years of experience in Medical devices complaints handling or any PMS activitiesWorking knowledge of appropriate global medical device regulations, requirements, and standards such as: CFR Parts 803, 806 and 820, ISO 13485, ISO 14971, EU Medical Device Directives/Regulations including MEDDEV GuidelinesFor Complaint Investigation – Mechanical problem analysis skill neededAn excellent communicator, both written and verbal Adopt to cross cultural differencesAbility to work in a timeline driven environmentProficiency using tools such as Trackwise, Sales force, Service Max

Job Description Summary Dossier lifecycle management, import license filing preparation and submission, Maintenance of database, Labeling review as per MDR 2017 and Legal metrology, RIM, cross functional colloboration, Job Description We are the makers of possible BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities. Why Join Us? A career at BD means learning and working alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. You will have the opportunity to help shape the trajectory of BD while leaving a legacy at the same time. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow and thrive. And find satisfaction in doing your part to make the world a better place. Become a maker of possible with us! Responsibilites To assist in the analysis and improvement of existing regulatory processes through regulatory activity immersion. Key responsibilities will include: Support regulatory efforts required to comply with new and existing regulations (e.g., FDA Medical Device Regulations and Guidelines, MDSAP) and other requirements including changes to FDA guidelines and applicable international standards Leading efforts for UDI including US, EU, and International requirements Support efforts for Technical File creation and remediation, collaborating with cross-functional teams for required content Support regulatory impact assessments for change controls and other RA/QA items Collect, store, and maintain regulatory documentation and assists in managing the data structure of the regulatory network (PIM, DMS, etc.) Proven ability to interpret medical device Quality System Regulations Assists in preparing, auditing, editing, and publishing registration documentation, as needed Support business export control (BEC) listing of product for release globally per RA requirements Support the review and approval of product labeling, promotional, and advertising materials as needed Performs other duties and assignments as required Click on apply if this sounds like you! Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. To learn more about BD visit: https://bd.com/careers Required Skills Optional Skills Primary Work Location IND Gurgaon - Signature Towers B Additional Locations Work Shift

Job Description: Senior Security Solutioning Architect Responsible for Security solution development, competitive costing, commercial proposition integration and business case alignment of Enterprise Security Services solutions supporting client business, applications and/or information technology environments. Have experience to influence client evaluation criteria and decision making. Solution scope includes ongoing delivery of services, Security and compliance requirements, services startup and transition, initial people, technology and process transformation as well as ongoing refresh, meeting client's specifications, strategic direction, technology context, and business needs. Confidently articulates all aspects of solution and convincingly communicates value to the stakeholders & client. Works individually, in teams or as leader, to determine customer requirements in complex and often ambiguous outsourced environments. Interacts effectively with team, pursuit leaders, internal governance and business leadership to advance sales efforts. Responsibilities: Opportunity Analysis: Understands which security offerings best address customer needs and business requirements Ongoing qualification of solution merits. Solution Design and Development: Provides security solutions to meet client requirements and is able to adapt to new requirements. Address Security and Compliance requirement. Identifies and evaluates value- add alternatives, solutions to those alternatives. Optimizes security solutions plus broader customer IT strategy. Takes end to end view of solution, ensuring elements within their responsibility deliver against the defined business outcomes, using standard components. Works with financial analysts to validate results versus applicable criteria. Captures and highlights Risks and any associated costs. Models multiple offerings/components of security domains. Understands interaction of deal variables (compliance, volumes, services, service level agreements, locations, and more) between tower components. Delivers and owns, accurate financial models that are logically structured and reflect the technical solution. Solution Leadership: Experience in Directing solution activities, decisions. Ability to lead service element integration within tower, tower sub-component volume tradeoffs. Provides security solutions to meet client needs inclusive of Regulatory and Compliance requirement and is able to adapt to new requirements. Solution-Pursuit Integration Anticipates, communicates and solutions to optimize inter-tower dependencies, overlaps, staff sharing, and more. Effectively integrates client tools, process adoption and delivery startup/transition need. Clearly defines all risks through governance process and works to mitigate. Client/Customer/Account Relationship Understands and addresses CISO / CxO issues. Applies consultative selling techniques to advance opportunities. Participates in/supports negotiation of technical contract elements. Provides solution advice, drives proposals, presentations, and other customer communications during pursuit. Input to security offering teams to bring in changes to offerings as per latest security trends and compliance needs. Education and Experience Required: Total experience of 12+ years in IT Security, mainly on security pre-sales, solution selling Technical university or Bachelor preferred Good exposure to Pre-Sales role involved in Cyber Security Solutioning and understands the Security Market Involvement in architecting and proposing the cyber security solutions to customer, experience in Managed Security Services market Knowledge and Skills: Demonstrates a broad knowledge of outsourcing services and solutions, with expertise in area of specialization. Preferably having any one of Security certifications like – CISSP, CCSP, CISA AND Security Product certifications. ITIL and PMP certifications are good to have. List of security domains on which solutioning exposure is required. Should be master in few (atleast in one) of the security domains backed up hand-on experience in both delivery and pre-sales. SIEM - MS Sentinel / SUMO / Splunk / QRadar IDM – Sailpoint / Forgerock / CyberArk / Microsoft / Broadcom / Okta APT Solution – Micorsoft / FireEye / PaloAlto / Checkpoint MDR / EDR Solution - Crowdstrike / Carbon black / Microsoft Endpoint Security - Symantec / McAfee / Trend Micro / Microsoft Network Security – PaloAlto / Checkpoint / Fortinet / Cisco GRC tools Cloud Security Good understanding of Security Risk & Compliance domain, Regulatory and Compliance requirements Awareness of Security Alliance partner offerings and directions, current industry news. Demonstrates thought leadership in Security domain. Demonstrates ability to work as the lead for components of large complex projects. Has in-depth understanding of the product and services portfolio roadmaps of multiple business units. Experience to handle POCs Recruitment fraud is a scheme in which fictitious job opportunities are offered to job seekers typically through online services, such as false websites, or through unsolicited emails claiming to be from the company. These emails may request recipients to provide personal information or to make payments as part of their illegitimate recruiting process. DXC does not make offers of employment via social media networks and DXC never asks for any money or payments from applicants at any point in the recruitment process, nor ask a job seeker to purchase IT or other equipment on our behalf. More information on employment scams is available here .

Application Security Engineer About Our ClientOur client is a leading name in the automotive and manufacturing sector, dedicated to innovation and excellence. Our commitment to cybersecurity in the automotive and manufacturing domains drives us to continually enhance our systems and protect our critical assets. Job Type: Full-Time | Experience Level: Mid-Senior Level | Location: Pune | Salary: Up to ₹1,700,000 INR per annum | Notice Period: 0–15 Days Role OverviewWe are seeking a talented Application Security Engineer to join our dynamic team on a permanent basis. This role focuses on designing and strengthening application security by leveraging expertise in endpoint security, Active Directory management, incident response, and various cybersecurity solutions including EDR, MDR, DLP, and vulnerability remediation. Your hands-on experience in remediating security issues will be pivotal in enhancing our security posture. Key ResponsibilitiesImplement and manage endpoint security solutions across desktops, laptops, and other devices.Oversee and modify Active Directory structures, ensuring changes align with security protocols.Lead incident response initiatives and coordinate with teams to promptly remediate vulnerabilities.Deploy and monitor EDR, MDR, DLP, and device encryption solutions to safeguard critical information.Execute effective patch management and vulnerability remediation strategies.Collaborate with cross-functional teams to provide actionable security monitoring and reporting. What We Look ForSkills:Expertise in endpoint security, Active Directory management (including modifications and changes), and incident response.Proven experience with EDR/MDR solutions, DLP implementation, and device encryption.Strong skills in patch management and vulnerability remediation.Background in the automotive or manufacturing cybersecurity domain.6 to 9 years of relevant experience demonstrating hands-on remediation, not just management. QualificationsRequired Experience: 6 - 9 years What We OfferCompetitive compensation and benefits packageProfessional growth and career development opportunitiesCollaborative and innovative work environmentWork-life balance

About KPMG in India KPMG entities in India are professional services firm(s). These Indian member firms are affiliated with KPMG International Limited. KPMG was established in India in August 1993. Our professionals leverage the global network of firms, and are conversant with local laws, regulations, markets and competition. KPMG has offices across India in Ahmedabad, Bengaluru, Chandigarh, Chennai, Gurugram, Hyderabad, Jaipur, Kochi, Kolkata, Mumbai, Noida, Pune, Vadodara and Vijayawada. KPMG entities in India offer services to national and international clients in India across sectors. We strive to provide rapid, performance-based, industry-focused and technology-enabled services, which reflect a shared knowledge of global and local industries and our experience Role & responsibilities: The candidate should be hands-on in managing Security Operations, SOC, Identify access management, Risk Management Should have worked on Blueprinting and Designing of SOC frameworks and implementation of SOC/SIEM solution and Enterprise Architecture Should be hands-on on security processes with good client and Market facing experience in India geography Should have worked on Designing, solutioning and Implementation of Cyber Security Frameworks - Security Operations Strategy, Vulnerability Management - Application & Infrastructure and Threat Intelligence and Analytics Preferred candidate profile : Should have worked on the below - M&A experience - Actively monitoring, analyzing & escalating SIEM alerts based on correlation rules, Active threat hunting on network flow, user behavior and threat intelligence Candidate should have expert level domain knowledge (Cyber Security), Threat Hunting, SIEM - Azure Sentinel, SIEM - (RSA / Splunk / LogRhythm/Qradar ), Ability to Comprehend Logs (HTTP, SMTP, Network), Operating systems and servers, Organizes Technical Sessions / Talks. Candidate should able to familiar with python Scripting & Windows Active Directory (Optional). Vulnerability Management Services - External & internal Vulnerability scanning, VMS tool Qualys & Kenna Administration, Application server & Vulnerability scanning Candidate should have expert level domain knowledge (Cyber Security), Vulnerability scans and recognizing vulnerabilities in security systems, Network analysis tools to identify vulnerabilities, Develop insights about the context of an organizations threat environment, Risk management processes, Network attack and a network attacks relationship to both threats and vulnerabilities. Candidate should have advance level understanding of Impact/risk assessments. Security Operations and Management experience - SOC Experience in Identity access, privilege access, vulnerability management Client facing - front end with the client- focused on engagements + Sales, BD + Capability Development Qualification: B.Tech / M.Tech/ MCA professional with 9-12 years of experience in the relevant role Should have strong hands on MS Power Point and MS Project Hands on experience and certification in any one SIEM (IBM QRadar, ArcSight, Azure Sentinel, Splunk) Security Certifications like CISSP, CISM, GIAC, Security+ etc Equal employment opportunity information KPMG India has a policy of providing equal opportunity for all applicants and employees regardless of their color, caste, religion, age, sex/gender, national origin, citizenship, sexual orientation, gender identity or expression, disability or other legally protected status. KPMG India values diversity and we request you to submit the details below to support us in our endeavor for diversity. Providing the below information is voluntary and refusal to submit such information will not be prejudicial to you.

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY-Cyber Security-TDR Senior (OT Lead Analyst – L3) As part of our EY-cyber security team, who shall work as SME for OT/IOT security solutions. The opportunity We’re looking for Senior consultant with expertise in OT/IOT security solutions. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of a new service offering. Your Key Responsibilities Acting as a member of the security operation centre with specific responsibility for the Operational Technology (OT) cyber securityProvide operational support for globally deployed enterprise deployment of OT network monitoring solution such as Nozomi, Claroty, Armis, DarkTrace, Azure Defender.Coordinates with operational team to assess the security of OT and Internet of Things (IoT) systems.Serves as the primary technical analyst and expert for the OT Network Monitoring service offering.Work directly with various organizational team(s) to help analyse OT & IoT network traffic patternsLeading and implementing improvements in cybersecurity threat monitoring, attack response methods, incident response plans and validation of physical security, IOT, and SCADA environmentsIn coordination with the Cyber Security team and other structures, be able to respond to the CSIRT and associated emergency preparedness proceduresAssist in the Development and improvement of the security incident response framework, including related standards and processes, and ensure effective implementationDevelop, conduct, and participate in Cyber Incident Response exercisesConfirm the rules and or configuration and policy settings that should apply on Security controls based on incidents and threat intelligence.Participate in OT security incident response through all phases.Conduct hunt for Indicators of Compromise (IOC) and APT Tactics, Techniques, and Procedures (TTP).Establish strong working relationships with manufacturing sites and related personnel to drive recommendations to improve the Cybersecurity posture. Skills And Attributes For Success Knowledge of a relevant OT Cyber Framework such as NIST 800-82 or ISA62443.Experience and expertise in control systems (ICS, SCADA, DCS, etc) and OT, IoT security – design, deployment and hardeningAbility to provide rapid and concise summaries of complex OT situationsIn-depth knowledge and understanding of how to handle and respond to OT security incidents as part of a specialised incident response teamStrong working knowledge and thorough understanding of Protective Monitoring, Vulnerability Monitoring, Threat Intelligence and Threat Hunting within OT dataKnowledge and understanding of a wide variety of security technologies and processesUp-to-date knowledge of current exploit techniques, vulnerability disclosures, data breach incidents, and security analysis techniques, combined with the understanding of the potential OT impact on the security postureWorking knowledge of cybersecurity policies and standards related to ICS/SCADA, OT/IoT Security solutions (e.g. Industrial IDS, Industrial Firewall etc)Knowledge and understanding of the OT world as related to different components such as HMI, PLC etc)Knowledge and understanding of tools used to protect industrial environmentUnderstanding of IT/OT/IoT communication protocols e.g., TCP/IP, UDP, DNP3, Modbus, IEC 61850, OPC, OPC UA, PROFINET, BLE, ZigbeeExperience supporting and troubleshooting industrial protocols such as OPC, Modbus TCP, HART, Foundation FieldbusUnderstand and be hands on, able to work with a wide range of Cyber Security related toolsets, SIEM, EDR/MDR, Vulnerability management, Microsoft and Linux operating systems, Firewalls, Networks, Deception tech, UEBA, IDS/IPS to name a fewAbility to work with minimal levels of supervision or oversight.Exposure to IOT/OT monitoring solutions (Claroty, Nozomi Networks, Armis, Azure Defender etc)Good knowledge and experience in Security Monitoring and Cyber Incident Response To qualify for the role, you must have B. Tech./ B.E/M.Tech/M.E with sound technical skillsStrong command on verbal and written English language.Demonstrate both technical acumen and critical thinking abilities.Strong interpersonal and presentation skills.8+ years’ overall experience in cyber security with minimum 4 years of Hands-on experience of operating/implementing OT/IOT Security solutions.Relevant certifications (Security +, CISSP, GCIA, GCIH, GMON, GICSP, GRID, GCCC etc) Ideally, you’ll also have People/Project management skills. What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues aroundOpportunities to develop new skills and progress your careerThe freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.

We at Phoenix Medical Systems Pvt. Ltd., based in Chennai and established in 1987, are committed to enhancing maternal and neonatal care by developing high-quality, affordable medical equipment. Our range includes infant warmers, incubators, phototherapy units, CPAP systems, and delivery beds. With a presence in over 60 countries, we serve hospitals and healthcare providers worldwide with reliable and innovative solutions. JOB OVERVIEWWe are seeking a Regulatory Specialist with a strong background in medical device regulatory submissions, particularly for US FDA (510(k)), EU MDR, and IMDR. The ideal candidate will have hands-on experience in compiling technical documentation, understanding global regulatory frameworks, and supporting cross-functional teams to ensure timely and compliant submissions. Key Responsibilities: To Prepare the technical dossier and ensure all technical and regulatory documents are accurately completed and submitted in a timely manner for 510(k) US FDA , European CE ( EU MDR) and CDSCO SubmissionTo Collaborate with cross-functional teams (R&D, Quality, Marketing) to define regulatory strategies and ensure alignment with regulatory requirements.To ensure products and submissions comply with FDA regulations, standards (e.g., 21 CFR 820), and guidance documents and EU MDR regulations. To address regulatory questions and manage any follow-up communications related to submissions. To monitor and track submission timelines and follow up on the status of pending approvals. Ensure timely responses to requests for additional information from the FDA.Continuously monitor changes to national/international/regulatory standards, guidance documents, and industry standards to ensure all submissions are in compliance with current regulatory requirements.To review product labeling, technical files, risk assessments, and other documentation for regulatory compliance.To Provide guidance and regulatory support to various departments, including Quality Assurance, Engineering, and Marketing.Maintain up-to-date, well-organized records of regulatory submissions and all related documentation, ensuring easy access for audits or reviews. Requirements:Education: Bachelor's / Master degree in Biomedical Engineering, Bio-Medical Instrumentation, or a related field.Experience: 2–3 years of relevant experience with direct involvement in 510(k) and EU MDR technical documentation.Knowledge:Strong understanding of ISO 13485, FDA 21 CFR 820, EU MDR, and IMDR regulations.Familiar with GSPR, risk management (ISO 14971), and clinical evaluation.Technical Skills: Experience using document management systems and regulatory submission tools.Communication: Excellent written and verbal communication skills.Problem-Solving: Ability to manage complex regulatory challenges independently.Teamwork: Proven ability to work cross-functionally with minimal supervision. Preferred Qualifications:Certification in ISO 13485, EU MDR and 510 (K) Experience with other geographical regulatory submissions Familiarity with international regulatory requirements

ce: 5-8 yrs Qualifications: You have successfully completed a course of studies in a technical or clinical field, preferably in engineering, medicine, medical engineering or (medical) informatics You can offer extensive professional experience in regulatory affairs for Software as Medical Device, SaaS, and/or cloud deployments You have a sound knowledge of international laws, standards and regulations for licensing medical devices, and of the business processes of medical device manufacturers (e.g. MDD/MDR, 21CFR 820; ISO 13485; IEC 62304; IEC 62366; ISO 14971) Your profile also includes a knowledge of regulatory requirements for the clinical evaluation of software for medical devices Experience in process or quality management would be an advantage Your Attributes And Skills: You are business-fluent in English, enabling you to operate successfully in our international context; knowledge of German would be an advantage Your personal qualities include a professional approach, skills in planning and organization, and cross-cultural experience You also have team and communication skills, initiative, and a structured, target-oriented way of working You champion the success of Siemens Healthineers with drive and passion Roles and Responsibilities: Ensure the medical device products comply with the regulations of the regions where it is planned to be marketed and sold. Maintaining a good understanding of new and existing regulations, standards and guidance that may impact their organization’s products and processes. Collaborate with the project teams and explaining regulatory requirements, procedures, and policies to all employees and stakeholders as necessary. Able to work in cross functional teams with good communication & interpersonal skills Collect, collate and evaluate product specific information in order to create and update the dossiers that must be submitted for new product licenses and license renewals. Prepare submissions for regulatory registration and renewals Maintaining data and files on country registrations for future reference, particularly in the event of an audit by a regulatory agency Preparing for and supporting internal, regulatory, and third-party audits as necessary

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY-Cyber Security-TDR Senior (OT Lead Analyst – L3) As part of our EY-cyber security team, who shall work as SME for OT/IOT security solutions. The opportunity We’re looking for Senior consultant with expertise in OT/IOT security solutions. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of a new service offering. Your Key Responsibilities Acting as a member of the security operation centre with specific responsibility for the Operational Technology (OT) cyber securityProvide operational support for globally deployed enterprise deployment of OT network monitoring solution such as Nozomi, Claroty, Armis, DarkTrace, Azure Defender.Coordinates with operational team to assess the security of OT and Internet of Things (IoT) systems.Serves as the primary technical analyst and expert for the OT Network Monitoring service offering.Work directly with various organizational team(s) to help analyse OT & IoT network traffic patternsLeading and implementing improvements in cybersecurity threat monitoring, attack response methods, incident response plans and validation of physical security, IOT, and SCADA environmentsIn coordination with the Cyber Security team and other structures, be able to respond to the CSIRT and associated emergency preparedness proceduresAssist in the Development and improvement of the security incident response framework, including related standards and processes, and ensure effective implementationDevelop, conduct, and participate in Cyber Incident Response exercisesConfirm the rules and or configuration and policy settings that should apply on Security controls based on incidents and threat intelligence.Participate in OT security incident response through all phases.Conduct hunt for Indicators of Compromise (IOC) and APT Tactics, Techniques, and Procedures (TTP).Establish strong working relationships with manufacturing sites and related personnel to drive recommendations to improve the Cybersecurity posture. Skills And Attributes For Success Knowledge of a relevant OT Cyber Framework such as NIST 800-82 or ISA62443.Experience and expertise in control systems (ICS, SCADA, DCS, etc) and OT, IoT security – design, deployment and hardeningAbility to provide rapid and concise summaries of complex OT situationsIn-depth knowledge and understanding of how to handle and respond to OT security incidents as part of a specialised incident response teamStrong working knowledge and thorough understanding of Protective Monitoring, Vulnerability Monitoring, Threat Intelligence and Threat Hunting within OT dataKnowledge and understanding of a wide variety of security technologies and processesUp-to-date knowledge of current exploit techniques, vulnerability disclosures, data breach incidents, and security analysis techniques, combined with the understanding of the potential OT impact on the security postureWorking knowledge of cybersecurity policies and standards related to ICS/SCADA, OT/IoT Security solutions (e.g. Industrial IDS, Industrial Firewall etc)Knowledge and understanding of the OT world as related to different components such as HMI, PLC etc)Knowledge and understanding of tools used to protect industrial environmentUnderstanding of IT/OT/IoT communication protocols e.g., TCP/IP, UDP, DNP3, Modbus, IEC 61850, OPC, OPC UA, PROFINET, BLE, ZigbeeExperience supporting and troubleshooting industrial protocols such as OPC, Modbus TCP, HART, Foundation FieldbusUnderstand and be hands on, able to work with a wide range of Cyber Security related toolsets, SIEM, EDR/MDR, Vulnerability management, Microsoft and Linux operating systems, Firewalls, Networks, Deception tech, UEBA, IDS/IPS to name a fewAbility to work with minimal levels of supervision or oversight.Exposure to IOT/OT monitoring solutions (Claroty, Nozomi Networks, Armis, Azure Defender etc)Good knowledge and experience in Security Monitoring and Cyber Incident Response To qualify for the role, you must have B. Tech./ B.E/M.Tech/M.E with sound technical skillsStrong command on verbal and written English language.Demonstrate both technical acumen and critical thinking abilities.Strong interpersonal and presentation skills.8+ years’ overall experience in cyber security with minimum 4 years of Hands-on experience of operating/implementing OT/IOT Security solutions.Relevant certifications (Security +, CISSP, GCIA, GCIH, GMON, GICSP, GRID, GCCC etc) Ideally, you’ll also have People/Project management skills. What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues aroundOpportunities to develop new skills and progress your careerThe freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY-Cyber Security-TDR Senior (OT Lead Analyst – L3) As part of our EY-cyber security team, who shall work as SME for OT/IOT security solutions. The opportunity We’re looking for Senior consultant with expertise in OT/IOT security solutions. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of a new service offering. Your Key Responsibilities Acting as a member of the security operation centre with specific responsibility for the Operational Technology (OT) cyber securityProvide operational support for globally deployed enterprise deployment of OT network monitoring solution such as Nozomi, Claroty, Armis, DarkTrace, Azure Defender.Coordinates with operational team to assess the security of OT and Internet of Things (IoT) systems.Serves as the primary technical analyst and expert for the OT Network Monitoring service offering.Work directly with various organizational team(s) to help analyse OT & IoT network traffic patternsLeading and implementing improvements in cybersecurity threat monitoring, attack response methods, incident response plans and validation of physical security, IOT, and SCADA environmentsIn coordination with the Cyber Security team and other structures, be able to respond to the CSIRT and associated emergency preparedness proceduresAssist in the Development and improvement of the security incident response framework, including related standards and processes, and ensure effective implementationDevelop, conduct, and participate in Cyber Incident Response exercisesConfirm the rules and or configuration and policy settings that should apply on Security controls based on incidents and threat intelligence.Participate in OT security incident response through all phases.Conduct hunt for Indicators of Compromise (IOC) and APT Tactics, Techniques, and Procedures (TTP).Establish strong working relationships with manufacturing sites and related personnel to drive recommendations to improve the Cybersecurity posture. Skills And Attributes For Success Knowledge of a relevant OT Cyber Framework such as NIST 800-82 or ISA62443.Experience and expertise in control systems (ICS, SCADA, DCS, etc) and OT, IoT security – design, deployment and hardeningAbility to provide rapid and concise summaries of complex OT situationsIn-depth knowledge and understanding of how to handle and respond to OT security incidents as part of a specialised incident response teamStrong working knowledge and thorough understanding of Protective Monitoring, Vulnerability Monitoring, Threat Intelligence and Threat Hunting within OT dataKnowledge and understanding of a wide variety of security technologies and processesUp-to-date knowledge of current exploit techniques, vulnerability disclosures, data breach incidents, and security analysis techniques, combined with the understanding of the potential OT impact on the security postureWorking knowledge of cybersecurity policies and standards related to ICS/SCADA, OT/IoT Security solutions (e.g. Industrial IDS, Industrial Firewall etc)Knowledge and understanding of the OT world as related to different components such as HMI, PLC etc)Knowledge and understanding of tools used to protect industrial environmentUnderstanding of IT/OT/IoT communication protocols e.g., TCP/IP, UDP, DNP3, Modbus, IEC 61850, OPC, OPC UA, PROFINET, BLE, ZigbeeExperience supporting and troubleshooting industrial protocols such as OPC, Modbus TCP, HART, Foundation FieldbusUnderstand and be hands on, able to work with a wide range of Cyber Security related toolsets, SIEM, EDR/MDR, Vulnerability management, Microsoft and Linux operating systems, Firewalls, Networks, Deception tech, UEBA, IDS/IPS to name a fewAbility to work with minimal levels of supervision or oversight.Exposure to IOT/OT monitoring solutions (Claroty, Nozomi Networks, Armis, Azure Defender etc)Good knowledge and experience in Security Monitoring and Cyber Incident Response To qualify for the role, you must have B. Tech./ B.E/M.Tech/M.E with sound technical skillsStrong command on verbal and written English language.Demonstrate both technical acumen and critical thinking abilities.Strong interpersonal and presentation skills.8+ years’ overall experience in cyber security with minimum 4 years of Hands-on experience of operating/implementing OT/IOT Security solutions.Relevant certifications (Security +, CISSP, GCIA, GCIH, GMON, GICSP, GRID, GCCC etc) Ideally, you’ll also have People/Project management skills. What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues aroundOpportunities to develop new skills and progress your careerThe freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.

Position Summary: ·Reporting Indirectly to the Quality Control Analyst, this position will be responsible for managing the day-to-day activities quality control function at Cepheid India Private Ltd. Bengaluru. ·Ensure compliance of quality control procedures and activities to MDR 2017, ISO 13485, Cepheid corporate quality system requirements. In this role, you will have the opportunity to: ·Perform inspections on incoming raw materials, in-process and finished products, write and record inspection documents. ·Ensure Cleaning /Decontamination of QC laboratory on daily basis before the start of any testing activity. ·Clean and maintain equipments inside Quality Control Lab as per protocol. ·Ensure the proper working of instruments and inform the QC Analyst and/or Lead in case of any discrepancies. ·Perform calibration activities for Genexpert modules whenever required. ·Ensure to maintain Quality control room, cleanroom standards, practices and housekeeping according to SOPs. ·Ensure the daily maintenance of QC related areas (NCR room, Retention room, Stability room, QC-lab) according to 5S standard. ·Assist QC associates for daily QC activities. ·Understand and adhere to safety policies and practices. ·Maintain the hard copy of all Quality Control related documents. ·Maintain the inventory for regular consumables. ·Read and follow Standard Operating Procedures (SOPs) and Quality control work instructions. ·Apply company policies and procedures to complete trainings. NOTE: All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities. MINIMUM REQUIREMENTS: Education and Experience (in years): ·B.Sc or M.Sc in any area of Life Sciences. 0 to 2 years of experience in manufacturing industry ex Pharma, Biotech, Healthcare, Automobile, electronics etc Preference will be given to candidates having experience in IVD/Manufacturing in the medical device, pharmaceutical or biotech industry, or equivalent combination of education and experience. Knowledge and skills: ·Ability to read SOPs in English is must. Understands Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) ·Must be a team player and able to demonstrate willingness and ability to provide assistance to co-workers. Ability to pay close attention to detail. ·Effective verbal and written communication skills ·Knowledge of Basic Computer Skills is a must ·Ability to solve basic math problems ·Able to identify each station of the machinery. Job Type: Full-time Pay: ₹21,000.00 - ₹22,000.00 per month Benefits: Food provided Health insurance Leave encashment Paid sick time Schedule: Rotational shift Supplemental Pay: Overtime pay Work Location: In person Application Deadline: 20/05/2025

About Janitri Janitri is a Med-tech company that develops IoT-based smart pregnancy and newborn monitoring devices. Apart from a recent feature in Shark Tank, Janitri has won numerous awards and accolades for its life-saving innovations. About the position: We are seeking a highly motivated and experienced Senior Regulatory and Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring compliance with regulatory requirements and maintaining high-quality standards throughout the product lifecycle of Class II medical devices. This role requires a deep understanding of regulatory affairs, quality management systems, and strong attention to detail. Roles and Responsibilities: Regulatory Compliance: Lead regulatory submissions (510(k), Technical Files, Design Dossiers) for Class II medical devices to regulatory authorities (FDA, Notified Bodies, etc.). Interpret and apply regulations (FDA QSR, ISO 13485, MDR, etc.) to ensure compliance of products and processes. Monitor changes in regulations and communicate potential impacts to relevant stakeholders. Quality Management Systems: Develop, implement, and maintain quality management systems (QMS) to ensure compliance with regulatory requirements and industry standards. Conduct internal audits and oversee external audits to assess QMS effectiveness and identify areas for improvement. Manage corrective and preventive action (CAPA) processes to address quality issues and prevent recurrence. Product Lifecycle Management: Provide regulatory guidance and support to cross-functional teams throughout the product life cycle, from product development to post-market surveillance. Review and approve design control documentation, including design inputs, verification/validation plans, and risk management activities. Support regulatory assessments of product changes and design modifications. Compliance Documentation: Prepare and maintain regulatory documentation, including regulatory submissions, technical documentation, and quality records. Ensure documentation is accurate, complete, and in compliance with applicable regulations and standards. Required Skills: Bachelor's degree in a relevant scientific or engineering field; advanced degree preferred. Minimum of 10+ years of experience in regulatory affairs and quality assurance within the medical device industry, with specific experience in Class II devices. In-depth knowledge of FDA regulations (21 CFR Part 820), ISO 13485, and other relevant standards. Experience with regulatory submissions, including 510(k) applications and Technical Files. Strong analytical skills and attention to detail. Excellent written and verbal communication skills. Ability to work effectively in a cross-functional team environment.

University degree or equivalent through experience and professional certification • A minimum of 7-10 years in Security and Loss prevention role, law enforcement or security-related profession • Extensive and up to date knowledge of Shrink Management and Data Analysis • Experience in managing or coordinating security investigations of complex nature • Knowledge of information security processes and systems • Experience in security auditing INSLP (Security & Loss Prevention) is hiring an SLP Specialist to support growth of the “SLP MDR Concessions Abuse Program” and help preventing losses via identification of abusive entity. The program is aimed at identifying and eliminating Concessions Abuse while preserving customer trust. The primary objective of the SLP Specialist is to provide security services, investigation and asset protection in designated area of responsibility, assist in mitigating product loss, and maintain customer satisfaction in accordance with INSLP guidelines and policies. The role is cross-functional and requires deep collaboration and influencing ability with stakeholders from business and corporate functions. SLP Specialist's day-to-day activities involve planning, organizing, coordinating, implementing and executing process and procedures laid down by the organization and the SLP function. As a part of the SLP MDR Concessions Abuse program, the SLP Specialist is required to deep dive into the Concessions request raised by customer, and conduct end-to-end investigation across customer, DA/network and seller to identify the abusive entity. SLP has outlined frameworks for investigation, and the SLP Specialist is bound to adhere to the investigation guidelines. Along with primarily supporting on Concessions investigations, the SLP Specialist will be required to provide on-ground intel useful in uncovering abuse MOs. In order to ensure network integrity, the SLP Specialist will be required to conduct risk assessment and process audit for the respective sites and work in accordance with the security policies and guidelines. Key job responsibilities Security Operation • Implementation and follow-up of Loss Prevention Plan in MDR Concessions Audits and Compliance • Conducting SLP audits and implementing SOPs • Surprise check and reports at LM (Last Mile) stations • Keeping the plans and SOPs updated • Periodical check of documentation • Adhering to SLAs defined for the SLP MDR Concessions Abuse Program Process Improvement and Loss Prevention • Process review, gap analysis and implementation of necessary improvements • Weekly, monthly and quarterly assessments • Loss prevention reporting • Working on feedbacks received from internal and external stakeholders • Follow up and completion of CAPA • Recommending loss prevention initiatives based on on-ground intel Loss Prevention Analysis and Investigation • Work closely with the SLP and CS teams to analyze the loss trends in MDR Concessions • Weekly loss trend analysis, identifying defects / abusive entities and working towards loss reduction • Conduct investigations by working closely with CS and support functions in SLP and Ops • Meeting the weekly investigation targets and submitting investigation reports • Sharing RCAs and PTG initiatives on shrink and unmet goals Loss Prevention experience Investigation/Security related certification Emergency Response / Crisis Management certification Training & Development experience Auditing and security investigations experience Exposure to MNC culture and dynamics Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit https://amazon.jobs/content/en/how-we-hire/accommodations for more information. If the country/region you’re applying in isn’t listed, please contact your Recruiting Partner.

University degree or equivalent through experience and professional certification • A minimum of 7-10 years in Security and Loss prevention role, law enforcement or security-related profession • Extensive and up to date knowledge of Shrink Management and Data Analysis • Experience in managing or coordinating security investigations of complex nature • Knowledge of information security processes and systems • Experience in security auditing INSLP (Security & Loss Prevention) is hiring an SLP Specialist to support growth of the “SLP MDR Concessions Abuse Program” and help preventing losses via identification of abusive entity. The program is aimed at identifying and eliminating Concessions Abuse while preserving customer trust. The primary objective of the SLP Specialist is to provide security services, investigation and asset protection in designated area of responsibility, assist in mitigating product loss, and maintain customer satisfaction in accordance with INSLP guidelines and policies. The role is cross-functional and requires deep collaboration and influencing ability with stakeholders from business and corporate functions. SLP Specialist's day-to-day activities involve planning, organizing, coordinating, implementing and executing process and procedures laid down by the organization and the SLP function. As a part of the SLP MDR Concessions Abuse program, the SLP Specialist is required to deep dive into the Concessions request raised by customer, and conduct end-to-end investigation across customer, DA/network and seller to identify the abusive entity. SLP has outlined frameworks for investigation, and the SLP Specialist is bound to adhere to the investigation guidelines. Along with primarily supporting on Concessions investigations, the SLP Specialist will be required to provide on-ground intel useful in uncovering abuse MOs. In order to ensure network integrity, the SLP Specialist will be required to conduct risk assessment and process audit for the respective sites and work in accordance with the security policies and guidelines. Key job responsibilities Security Operation • Implementation and follow-up of Loss Prevention Plan in MDR Concessions Audits and Compliance • Conducting SLP audits and implementing SOPs • Surprise check and reports at LM (Last Mile) stations • Keeping the plans and SOPs updated • Periodical check of documentation • Adhering to SLAs defined for the SLP MDR Concessions Abuse Program Process Improvement and Loss Prevention • Process review, gap analysis and implementation of necessary improvements • Weekly, monthly and quarterly assessments • Loss prevention reporting • Working on feedbacks received from internal and external stakeholders • Follow up and completion of CAPA • Recommending loss prevention initiatives based on on-ground intel Loss Prevention Analysis and Investigation • Work closely with the SLP and CS teams to analyze the loss trends in MDR Concessions • Weekly loss trend analysis, identifying defects / abusive entities and working towards loss reduction • Conduct investigations by working closely with CS and support functions in SLP and Ops • Meeting the weekly investigation targets and submitting investigation reports • Sharing RCAs and PTG initiatives on shrink and unmet goals Loss Prevention experience Investigation/Security related certification Emergency Response / Crisis Management certification Training & Development experience Auditing and security investigations experience Exposure to MNC culture and dynamics Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit https://amazon.jobs/content/en/how-we-hire/accommodations for more information. If the country/region you’re applying in isn’t listed, please contact your Recruiting Partner.

University degree or equivalent through experience and professional certification • A minimum of 7-10 years in Security and Loss prevention role, law enforcement or security-related profession • Extensive and up to date knowledge of Shrink Management and Data Analysis • Experience in managing or coordinating security investigations of complex nature • Knowledge of information security processes and systems • Experience in security auditing INSLP (Security & Loss Prevention) is hiring an SLP Specialist to support growth of the “SLP MDR Concessions Abuse Program” and help preventing losses via identification of abusive entity. The program is aimed at identifying and eliminating Concessions Abuse while preserving customer trust. The primary objective of the SLP Specialist is to provide security services, investigation and asset protection in designated area of responsibility, assist in mitigating product loss, and maintain customer satisfaction in accordance with INSLP guidelines and policies. The role is cross-functional and requires deep collaboration and influencing ability with stakeholders from business and corporate functions. SLP Specialist's day-to-day activities involve planning, organizing, coordinating, implementing and executing process and procedures laid down by the organization and the SLP function. As a part of the SLP MDR Concessions Abuse program, the SLP Specialist is required to deep dive into the Concessions request raised by customer, and conduct end-to-end investigation across customer, DA/network and seller to identify the abusive entity. SLP has outlined frameworks for investigation, and the SLP Specialist is bound to adhere to the investigation guidelines. Along with primarily supporting on Concessions investigations, the SLP Specialist will be required to provide on-ground intel useful in uncovering abuse MOs. In order to ensure network integrity, the SLP Specialist will be required to conduct risk assessment and process audit for the respective sites and work in accordance with the security policies and guidelines. Key job responsibilities Security Operation • Implementation and follow-up of Loss Prevention Plan in MDR Concessions Audits and Compliance • Conducting SLP audits and implementing SOPs • Surprise check and reports at LM (Last Mile) stations • Keeping the plans and SOPs updated • Periodical check of documentation • Adhering to SLAs defined for the SLP MDR Concessions Abuse Program Process Improvement and Loss Prevention • Process review, gap analysis and implementation of necessary improvements • Weekly, monthly and quarterly assessments • Loss prevention reporting • Working on feedbacks received from internal and external stakeholders • Follow up and completion of CAPA • Recommending loss prevention initiatives based on on-ground intel Loss Prevention Analysis and Investigation • Work closely with the SLP and CS teams to analyze the loss trends in MDR Concessions • Weekly loss trend analysis, identifying defects / abusive entities and working towards loss reduction • Conduct investigations by working closely with CS and support functions in SLP and Ops • Meeting the weekly investigation targets and submitting investigation reports • Sharing RCAs and PTG initiatives on shrink and unmet goals Loss Prevention experience Investigation/Security related certification Emergency Response / Crisis Management certification Training & Development experience Auditing and security investigations experience Exposure to MNC culture and dynamics Our inclusive culture empowers Amazonians to deliver the best results for our customers. If you have a disability and need a workplace accommodation or adjustment during the application and hiring process, including support for the interview or onboarding process, please visit https://amazon.jobs/content/en/how-we-hire/accommodations for more information. If the country/region you’re applying in isn’t listed, please contact your Recruiting Partner.

The Product Owner is responsible for the definition and delivery of a part of a product from a customer and market requirement point of view - regarding content, prioritization, quality and customer excitement for a given cost and time frame. Responsible for a part of the product through the product life cycle from the definition to the phase-out. Provides the associated development teams with priorities and expertise regarding the product and ensures completeness and consistency of the derived requirements within the part of the product. Responsible for definition and delivery of a part of a product from a customer and market requirement point of view, working with one or several development teams. Internal Interactions: Product Line Manager, Product Manager, Project Manager, Quality Manager, Development Team (e.g. Scrum Master, System Analyst, Architect, Developers, Testers), Usability Engineer, other stakeholders (e.g. Business Units), SCM (Enabling) & Customer Service teams, Technical Writers, etc. External Interactions: Customers – Radiologists, Radiology Technicians, Hospital Administrators, IT Administrators etc. What are my tasks? Elicit and collect stakeholder requests Define and prioritize Market Requirements Analyze Market Requirements (e.g. initiate and manage concepts for complex Market Requirements) Derive, prioritize and communicate Software Requirements Create Software Requirement Specifications (i.e. problem part) Coach/support development team's questions and resolve conflict regarding features and requirements Analyze and decide complaints and defects/bugs Achieve commitments with and motivate development teams, assist development teams in attaining maximum effective sustainable pace for development Ensure quality by evaluating results of iterations and either approve/ accept or reject results based on DONEness criteria Support effort estimations of development teams Analyze change request entries and prioritize with other product backlog items Coordinate cross-feature-area development with peers to facilitate prioritized product development Deliver input for project management Support roll-out of the system, presentation, workshops, training for sales and engineering What do I need to know to qualify for this job? Qualification: A Bachelors / master’s degree in engineering and / or MCA or equivalent. Work Experience: 12 to 15 years. Desired Knowledge & Experience: Healthcare market. Product knowhow and customer understanding Sound knowledge of Clinical Workflows and Healthcare IT, especially in the area of Radiology. Healthcare Industry standards like DICOM and IHE Knowledge in Medical Imaging domain Good understanding of software systems categorized as Medical Device Basic understanding of Legal regulations and standards applicable for medical devices, affecting safety aspects(i.e. FDA 21CFR820QSR, MDR, ISO 13485) Exposure to agile methodology Good programming skills & should have worked for most of the time in software programming roles. Thorough experience in Requirements Engineering, Usability Engineering, and feature definition activities. Product Lifecycle Management & Software development cycle experience Experience in CT & MR modalities & medical imaging tool development is an added advantage. What experience do I need to have? Professional: Several years of experience in the medical device/ healthcare industry (e.g. as a Product Owner, System Analyst, Technology Lead, Lead Architect etc.), expertise in clinical and radiological workflows, experience in image processing. Several years of experience in IT product or solution business. Project / Process: Several years of experience in requirements engineering and SW development. Experience in agile development projects, preferably in Product Owner role. Leadership: Experience with managing internationally staffed teams, management and balancing of different stakeholder expectations, management of product definitions. Ideally several years experience in technical leadership role and communicating direction and coaching others. Intercultural: Experience with international/ intercultural teams, conduction of workshops with international development partners and customers. What else do I need to be strong at? Self driven and takes Initiatives Decision making skills Result orientation Self motivated and provides motivation and inspiration to the team Strong Analytical and Problem-Solving Skills. Strong team player and networking skills Strong written and oral communication skills. Strong interpersonal skills Strong customer focus

The Product Owner is responsible for the definition and delivery of a part of a product from a customer and market requirement point of view - regarding content, prioritization, quality, and customer excitement for a given cost and time frame. Responsible for a part of the product through the product life cycle from the definition to the phase-out. Provides the associated development teams with priorities and expertise regarding the product and ensures completeness and consistency of the derived requirements within the part of the product. Responsible for definition and delivery of a part of a product from a customer and market requirement point of view, working with one or several development teams. Internal Interactions: Product Line Manager, Product Manager, Project Manager, Quality Manager, Development Team (e.g. Scrum Master, System Analyst, Architect, Developers, Testers), Usability Engineer, other stakeholders (e.g. Business Units), SCM (Enabling) & Customer Service teams, Technical Writers, etc. External Interactions: Customers – Hospital Administrators, IT Administrators etc. What are my tasks? Elicit and collect stakeholder requests Define and prioritize Market Requirements Analyze Market Requirements (e.g. initiate and manage concepts for complex Market Requirements) Derive, prioritize, and communicate Software Requirements Create Software Requirement Specifications (i.e. problem part) Coach/support development team's questions and resolve conflict regarding features and requirements Analyze and decide complaints and bugs/charms Achieve commitments with and motivate development teams, assist development teams in attaining maximum effective sustainable pace for development Ensure quality by evaluating results of iterations and either approve/ accept or reject results based on DONEness criteria Support effort estimations of development teams Analyze change request entries and prioritize with other product backlog items Coordinate cross-feature-area development with peers to facilitate prioritized product development Deliver input for project management Support roll-out of the system, presentation, workshops, training for sales and engineering What do I need to know to qualify for this job? Qualification: A Bachelors / master’s degree in engineering and / or MCA or equivalent. Work Experience: 12 to 15 years. Desired Knowledge & Experience: Knowledge on medical product Infrastructure, deployment technologies and non-medical software development. Knowhow of Containers, Kubernetes, Dockers and other Containerization technologies. Strong experience in Virtual Appliances, centralized logging, DBs and cloud hosting of applications. Exposure to CI/CD pipeline. Healthcare market - Product knowhow and customer understanding Knowledge of Clinical Workflows and Healthcare IT, especially in the area of Radiology. Healthcare Industry standards like DICOM and IHE is desirable. Basic understanding of Legal regulations and standards applicable for medical devices, affecting safety aspects(i.e. FDA 21CFR820QSR, MDR, ISO 13485) Exposure to Agile methodology Good programming skills & should have worked for most of the time in software programming roles. Thorough experience in Requirements Engineering, Usability Engineering, Cyber Security and feature definition activities. Product Lifecycle Management & Software development cycle experience What experience do I need to have? Professional: Several years of experience in the medical device/ healthcare industry (e.g. as a Product Owner, System Engineer, System Analyst, Technology Lead, Architect etc.). Several years of experience in IT product or solution business and service topics. Project / Process: Several years of experience in requirements engineering and SW development. Ideally, IT integration experience. Experience in agile development projects, preferably in Product Owner role. Leadership: Experience with managing internationally staffed teams, management and balancing of different stakeholder expectations, management of product definitions. Ideally several years experience in technical leadership role and communicating direction and coaching others. Intercultural: Experience with international/intercultural teams, conduction of workshops with international development partners and customers. What else do I need to be strong at? Self driven and takes Initiatives Decision making skills Result orientation Self motivated and provides motivation and inspiration to the team Strong Analytical and Problem-Solving Skills. Strong team player and networking skills Strong written and oral communication skills. Strong interpersonal skills Strong customer focus

Job Summary If you're a seasoned cybersecurity professional looking to lead in a 24x7 SOC, work with top-tier security tools, we'd love to hear from you! Job Description Company Overview: Outsourced is a leading ISO certified India & Philippines offshore outsourcing company that provides dedicated remote staff to some of the world's leading international companies. Outsourced is recognized as one of the Best Places to Work and has achieved Great Place to Work Certification. We are committed to providing a positive and supportive work environment where all staff can thrive. As an Outsourced staff member, you will enjoy a fun and friendly working environment, competitive salaries, opportunities for growth and development, work-life balance, and the chance to share your passion with a team of over 1000 talented professionals. Location: [Remote] Employment Type: Full-time Experience Level: Senior (5+ years in cybersecurity, 2+ years in SOC/MSP) Key Responsibilities ✔ Security Operations & Engineering: Provide L2/L3 support for NextGen Firewalls (Fortinet, Cisco, Check Point), Cloud SASE (Zscaler, Netskope), WAF (Cloudflare), PAM (CyberArk), and related security technologies.Troubleshoot and optimize network segmentation, URL filtering, packet inspection, PKI/certificates, and cloud security (AWS/Azure).Assist in incident response (IR) and collaborate with the MDR (Watcher) team to mitigate threats. ✔ SOC Process & Client Engagement: Improve SOC workflows, documentation, and best practices.Engage with managed service clients, providing security guidance and recommendations.Contribute to RFP responses, security projects, and strategic SOC enhancements. ✔ Automation & Cloud Security: Leverage IaC (Infrastructure as Code – Terraform, Ansible) for cloud security deployments.Develop scripting (Python, PowerShell, Bash) solutions to automate SOC tasks. ✔ Mentorship & Leadership: Guide junior engineers, fostering a collaborative, high-performance SOC culture.Lead knowledge-sharing sessions and contribute to team upskilling. Essential Qualifications: ✅ 5+ years in cybersecurity, with 2+ years in a SOC or MSP environment (L2/L3 support). ✅ Expertise In NextGen Firewalls (Fortinet, Cisco, Check Point), Cloud SASE (Zscaler), WAF (Cloudflare), PAM (CyberArk).Network security (segmentation, URL filtering, PKI, cloud security – AWS/Azure). ✅ Strong troubleshooting skills – able to resolve issues under tight deadlines. ✅ Process-driven mindset – improves SOC workflows, documentation, and best practices. ✅ Stakeholder management – comfortable briefing clients and advising on security best practices. ✅ Leadership potential – mentors junior engineers and drives team success. Desirable Skills Advanced certifications (CyberArk Defender, Zscaler, Fortinet NSE, CISSP, CCSP). Scripting/Automation (Python, PowerShell, Bash) for SOC efficiency. Cloud security experience (AWS/Azure, IaC – Terraform, Ansible). Home lab / security projects (demonstrates passion for hands-on learning). Active in cybersecurity communities (forums, webinars, ISC2, ISACA). What We Offer Health Insurance: We provide medical coverage up to 20 lakh per annum, which covers you, your spouse, and a set of parents. This is available after one month of successful engagement.Professional Development: You'll have access to a monthly upskill allowance of ₹5000 for continued education and certifications to support your career growth.Leave Policy: Vacation Leave (VL): 10 days per year, available after probation. You can carry over or encash up to 5 unused days.Casual Leave (CL): 8 days per year for personal needs or emergencies, available from day one.Sick Leave: 12 days per year, available after probation.Flexible Work Hours or Remote Work Opportunities – Depending on the role and project.Outsourced Benefits such as Paternity Leave, Maternity Leave, etc.

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. Essential Functions With minimal supervision, authors (writes/edits) high-quality medical writing deliverables (i.e., clinical, safety, regulatory, device, diagnostics, or disclosures documents) across all phases of clinical research and in various therapeutic areas including but not limited to: protocols, protocol amendments, study reports, patient narratives, IBs, ICFs, CEPs/CERs, DSURs, and plain language summaries, as well as more complex documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission‑level documents).Supervises, trains, and mentors less experienced medical writers, as necessary.Adheres to established regulatory standards/guidelines including but not limited to: ICH E3/E6(R2), EU MDR/IVDR, Company standard operating procedures, client standards, and Company- and/or client-approved templates.Strives to complete medical writing deliverables on time and within budget.With minimal supervision, manages client expectations and interacts and communicates directly with clients, leads team meetings (e.g., project kickoff, comment review), and manages the deliverable timelines.Interacts and collaborates with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc., as needed, to produce writing deliverables.Coordinates QC reviews of documents and maintains audit trails of changes as applicable.Reviews statistical analysis plans and table/figure/listing shells (as applicable) for appropriate content, grammar, format, and consistency.If requested by supervisor, performs QC review (e.g., reviews in-text tables against statistical output).Performs peer review of documents written by other medical writers, as required.Assists with project-related administrative tasks (e.g., creates and maintains timelines, updates deliverable trackers, hosts internal/client meetings).Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to medical writing.Understands budget specifications for assigned deliverables, works within the budgeted hours, and communicates out-of-scope tasks to medical writing leadership.Supports multiple medical writing deliverables/projects simultaneously and manages own workload with minimal intervention from management team.Brings issues and potential concerns to line manager/client oversight manager’s attention and proposes possible solutions for consideration by management team.Participates in departmental initiatives (e.g., process improvement, lunch and learns, etc.).Other duties as assigned. Necessary Skills And Abilities Advanced knowledge of clinical research principles and demonstrated ability to interpret and present clinical data and other complex information.Advanced understanding of FDA (and other regulatory bodies as relevant to their role) and applicable regulations and guidelines.Advanced understanding of regulatory submission requirements and processes.Computer technology proficiency and expert word processing skills in MS Word, including required proficiency with tables, graphs, and figures.Exceptional project management skills and strong communication skills with a high attention to detail and quality.English language proficiency and familiarity with American Medical Association (AMA) style.Strong experience in relationship building and strategic collaboration on key business accounts.Thinks proactively, takes initiative, and willingly takes on new challenges.Ability to identify areas of concern or inefficiency and propose solutions for consideration by the management team to improve overall efficiency and quality of deliverables.Works independently with exceptional time-management skills and contacts management team proactively when additional support and resources are needed.Works effectively in a collaborative team environment.Demonstrates a growth mindset and positive outlook in all work activities. Educational Requirements Bachelor’s degree or higher, preferably in medical or scientific discipline. Experience Requirements Minimum of 6 years of experience in writing clinical and/or regulatory documents for drugs, biologics, and/or medical devices/diagnostics for a contract research organization, pharmaceutical company, or biotechnology company.Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case‑by‑case basis. We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Job ID/Reference Code INFSYS-NAUKRI-210982 Work Experience 5-8 Job Title Medical Device - Mechanical Engineer Responsibilities A day in the life of an Infoscion As part of the Infosys delivery team, your primary role would be to interface with the client for quality assurance, issue resolution and ensuring high customer satisfaction. You will understand requirements, create and review designs, validate the architecture and ensure high levels of service offerings to clients in the technology domain. You will participate in project estimation, provide inputs for solution delivery, conduct technical risk planning, perform code reviews and unit test plan reviews. You will lead and guide your teams towards developing optimized high quality code deliverables, continual knowledge management and adherence to the organizational guidelines and processes. You would be a key contributor to building efficient programs/ systems and if you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you!If you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you! Technical and Professional Requirements: Primary Skills: CTQ, QMS, ISO 13485, Design Documentation, CAPA, DHF Preferred Skills: Technology->CAD->CAD - Others Educational Requirements Master Of Engineering,Master Of Technology,Bachelor Of Engineering,Bachelor Of Technology Service Line Engineering Services * Location of posting is subject to business requirements

Key Areas of responsibility include but are not limited to: Responsible for New Image processing topics during medical device development Drives implementation of new imaging algorithms to improve X-ray image quality based on clinical feedback and/or new developments Brings deep expertise in embedded systems to derive architectural decisions impacting image processing implementation topics Key member of the Product Steering Group (PSG) / Product Lifecycle Group (PLG) and checks the dependencies to the product risk management in case of product changes ([R06]), Assists/ Supports product compliance testing Supports in requirements analysis and development of the system functional specifications Expertise in risk engineering during medical device development will be a plus The System Engineer of AT is actively and collaboratively involved in the continuous improvement of processes in his/her area of responsibility. Job knowledge, skills, and experience Bachelor/ Master in Electronics/ Electrical engineering with at least 5-6 years of work experience, preferably with X-ray diagnostic medical products Hands-on experience in clinical image processing and image quality topics A go-getter driving interactions between other team members, stakeholders from other Siemens Healthineers global locations and internal factory teams ensuring things get done. A good background of MDR, Medical device Regulatory affairs, IEC Standards and Medical device Risk Management is a plus. Exposure to risk engineering, user documentation and/or IEC compliance testing. Candidates with exposure to end-end medical device product development highly preferred